(270 days)
The Flexipet® Denuding Pipettes are intended to be used for blastomere or polar body manipulation, occyte and embryo manipulation, or denuding.
The Flexipet® Manipulation Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, blastocyst handling, and manipulation of the oocyte-cumulus complex.
The Flexipet® Denuding Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 120 µm to 170 µm on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.
The Flexipet® Manipulation Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 80 um to 600 um on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| MEA (Mouse Embryo Assay) | ≥80% 1-cell embryos developed to blastocyst within 96 hours. | The predetermined acceptance criterion was met. |
| LAL (Limulus Amebocyte Lysate) |
§ 884.6130 Assisted reproduction microtools.
(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.